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Numeta G 16% E® (nutrient solution for term infants and children up to 2 years of age): Possible risk of hypermagnesemia PDF, 89KB, File is accessible Date: 09. October 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: nutrient solution for term infants and children up to 2 years of age

The company Baxter Deutschland GmbH is sending out information that administration of the medicinal product Numeta G 16% E® to term infants and children up to 2 years of age can possibly lead to the risk of hypermagnesemia.

Dear Doctor Letter (Rote-Hand-Brief) on short-acting beta-agonists/beta 2-sympathomimetic agents (SABAs) for obstetric indications - including Partusisten® (fenoterol): Restrictions of indication PDF, 818KB, File is accessible Date: 01. October 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fenoterol

The company Boehringer Ingelheim communicates important restrictions regarding the use of short-acting beta-agonists/beta 2-sympathomimetic agents (SABAs) for obstetric indications.

Application for changing the legal status Date: 26. September 2013 Topics: Pharmakovigilanz Arzneimittelsicherheit Type: Article

Application for changing the legal status

Dear Doctor Letter (Rote-Hand-Brief) on Lariam® (mefloquine): Risk of neuropsychiatric and other serious adverse reactions as well as inclusion of new contraindications PDF, 2MB, File is accessible Date: 10. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: mefloquine

Important information regarding new contraindications (Blackwater fever, severe impairment of liver function) as well as on the risk of neuropsychiatric and other serious adverse reactions under Lariam® (mefloquine) for malaria …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing risperidone or paliperidone: Risk of an intraoperative floppy iris syndrome (IFIS) PDF, 817KB, File is accessible Date: 09. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: risperidone, paliperidone

Important information on the risk of an intraoperative floppy iris syndrome (IFIS) in connection with administration of risperidone or paliperidone to patients undergoing cataract surgery.

Information Letter on the new anticoagulants Eliquis® (apixaban), Pradaxa® (dabigatran etexilate) and Xarelto® (rivaroxaban): Reducing the risk of haemorrhages PDF, 108KB, File is accessible Date: 06. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: apixaban

The marketing authorisation holders request observation of risk factors for haemorrhages as well as of dosage instructions, contraindications, warnings and precautionary measures for use in order to reduce the risk of haemorrhages.

Information Letter on clopidogrel: Risk of acquired haemophilia PDF, 145KB, File is accessible Date: 04. September 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: clopidogrel

The marketing authorisation holders are circulating information on a small number of cases of acquired haemophilia associated with clopidogrel treatment in patients without a history of haemostasis.

Zyvoxid® 2 mg/ml solution for injection (linezolid): limited supply with immediate effect PDF, 116KB, File is accessible Date: 30. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: linezolid

The company Pfizer Pharma GmbH is circulating information that with immediate effect the medicinal product Zyvoxid® 2 mg/ml solution for injection is available again to a limited extent.

Dear Doctor Letter (Rote-Hand-Brief) on Imnovid® (pomalidomide): Information on important aspects of clinical use PDF, 591KB, File is accessible Date: 28. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pomalidomide

The marketing authorisation holder Celgene is circulating information on important aspects regarding the clinical use of the new medicinal product Imnovid® (pomalidomide).

Dear Doctor Letter (Rote-Hand-Brief) on Neupogen® (filgrastim) and Neulasta® (pegfilgrastim): Risk of capillary leak syndrom PDF, 567KB, File is accessible Date: 26. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: filgrastim

The marketing authorisation holder Amgen GmbH is circulating information on an adverse effect, the capillary leak syndrome (CLS), associated with the treatment of patients with cancer and/or healthy donors with Neupogen® (filgrastim) or Neulasta®

Diane® 35 and generic drugs: risk of thromboembolic events Date: 23. August 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: cyproterone acetate/ethinylestradiol

In a notice dated 8 August 2013, the Federal Institute for Drugs and Medical Devices has ruled the realisation of the European Commission's implementing decision on medicinal products containing the combination cyproterone acetate/ethinylestradiol.

Information Letter on oral ketoconazole-containing medicinal products (Nizoral® tablets): Suspension of marketing authorisation due to serious liver damage
PDF, 75KB, File is accessible
Date: 22. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ketoconazole

After an EU-wide review of the risk of hepatotoxicity under ketoconazole for treatment of fungal infections, the EMA recommends the suspension of the marketing authorisation for Nizoral® tablets (oral ketoconazole-containing medicinal …

Zyvoxid® 2 mg/ml solution for injection (linezolid): Temporary shortage
PDF, 148KB, File is accessible
Date: 15. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: linezolid

The company Pfizer Pharma GmbH is circulating information that the medicinal product Zyvoxid® 2 mg/ml solution for injection can currently not be supplied. This shortage is the result of manufacturing problems of one of the external …

Mucosolvan® Solution for injection (ambroxol hydrochloride)
PDF, 87KB, File is accessible
Date: 09. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ambroxol hydrochloride

Information on mixing with commercially available 5% glucose solution for infusion.

LInformation Letter on Roferon®-A (interferon alfa-2a)
PDF, 2MB, File is accessible
Date: 07. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: interferon alfa-2a

The marketing authorisation holder Roche Pharma is circulating an information letter on a temporary shortage in the supply of Roferon®-A due to relocation of the production site.

Information Letter on PegIntron® (peginterferon alfa-2b)
PDF, 64KB, File is accessible
Date: 02. August 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: peginterferon alfa-2b

Information on the correct use of the new pre-filled injection pen.

Dear Doctor Letter (Rote-Hand-Brief) on Erivedge® (vismodegib) PDF, 3MB, File is accessible Date: 31. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: vismodegib

Important information for safe use, including information on contraceptive programmes.

Information Letter on VOTRIENT® (pazopanib)
PDF, 169KB, File is accessible
Date: 30. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: pazopanib

Important change to frequency of serum liver test monitoring for hepatotoxicity.

DepoCyte® 50 mg injectable suspension (liposomal cytarabine for intrathecal injection): Back on the market as of 1 August 2013
PDF, 175KB, File is accessible
Date: 25. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: liposomal cytarabine

As of 1 August 2013, DepoCyte® will be available again regularly on the German market.

Dear Doctor Letter (Rote-Hand-Brief) on Pedea® (ibuprofen as solution for injection): Shortage PDF, 401KB, File is accessible Date: 22. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ibuprofen

A temporary shortage in the supply of the medicinal product Pedea® for treatment of a haemodynamically significant patent ductus arteriosus Botalli in preterm newborn infants less than 34 weeks of gestational age has arisen due to the …

PlasmaVolume Redibag® by the company Baxter: Voluntary recall of the medicinal product PDF, 116KB, File is accessible Date: 18. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: hydroxyethyl starch

The marketing authorisation holder Baxter is circulating information that its medicinal product PlasmaVolume Redibag® (active substance: hydroxyethyl starch (HES)) is being recalled voluntarily from the market and requests to stop using this …

Information Letter on Zofran® (ondansetron) and generic medicinal products: Risk of QTc prolongation PDF, 548KB, File is accessible Date: 18. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ondansetron

This communication contains updated information regarding intravenous use of ondansetron for prevention and treatment of chemotherapy-induced nausea, retching and vomiting (CINV), as well as new recommendations for repeated administration and …

Medicinal products containing diclofenac: Cardiovascular risks PDF, 249KB, File is accessible Date: 16. July 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: diclofenac

The marketing authorisation holders of systemically acting medicinal products containing diclofenac are sending out information that new contraindications and warnings for these medicinal products have been decided following the Europe-wide …

List of medicines under additional monitoring Date: 15. July 2013 Topics: Pharmakovigilanz Type: Article

List of medicines under additional monitoring

Medicinal products containing codeine for treatment of pain in children: Key messages from the PRAC for consideration Date: 11. July 2013 Topics: Pharmakovigilanz Type: Risk information

Active substance: codeine

At its June meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) issued a document with key messages that should be considered when using medicinal products containing codeine for pain relief in children.

Fumaderm® initial/Fumaderm® (fumaric acid derivatives): Avoiding the risk of opportunistic infections by adhering to regular laboratory controls and observing further warnings PDF, 679KB, File is accessible Date: 26. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: fumaric acid derivatives

The company Biogen Idec GmbH points out that it is absolutely necessary when using the medicinal products Fumaderm® initial/Fumaderm® to observe the warnings given in the Summary of Product Characteristics with regard to regular monitoring of …

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing tetrazepam (e.g. Musaril®): Ruling of suspension due to rare, serious skin reactions PDF, 331KB, File is accessible Date: 25. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: tetrazepam

The company Sanofi-Aventis Deutschland GmbH is sending out information that the marketing authorisations for medicinal products containing tetrazepam (e.g. Musaril®) have been suspended in the EU.

Trobalt® (retigabine): Risk of pigmentary changes PDF, 343KB, File is accessible Date: 24. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: retigabine

The company GlaxoSmithKline is sending out information that treatment with the medicinal product Trobalt® can lead to pigmentary changes of eye tissues, including the retina, as well as of the skin, lips and/or nails.

Dear Doctor Letter (Rote-Hand-Brief) on Revlimid® (lenalidomide): Important aspects with regard to clinical use PDF, 260KB, File is accessible Date: 20. June 2013 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: lenalidomide

Celgene Europe Ltd. is sending out information on important aspects regarding the clinical use of Revlimid® (lenalidomide) for which a further indication was recently licenced.

Combined use of ACE-inhibitors, angiotensin II receptor antagonists or aliskiren: recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) within a European safety review Date: 14. June 2013 Topics: Pharmakovigilanz Type: Risk Assessment Procedures

Active substance: ACE-inhibitors | angiotensin II receptor antagonists or aliskiren

The BfArM issues information on the PRAC recommendation within the European safety review according to Article 31 of Directive 2001/83/EC.